Orthotic inserts have been used for many years in an effort to correct the alignment and functional pathology of the human foot. U.S. Pat. No. 454,342 shows one of the earliest orthotic inserts used for the supportive, static, correction of a flat foot deformity. Such an insert is generally known as an "arch support."
More recent orthotic inserts allow for the variable placement of static components. For example, in U.S. Pat. No. 4,800,657, the insert provides adjustment plugs to "fine tune" the supportive contour of the insert. Another recent example is U.S. Pat. No. 4,841,648 which shows a supportive insole that can be modified by the user. The insole consists of different attachable insole pieces which vary in size, shape and density.
Although modern insert design, which is generally supportive in structure, can be indirectly effective in treating lower extremity functional pathology, they also can and often do fail to achieve a noticeable functional improvement. Ideally, a foot orthosis should be functional, supportive and comfortable. A foot orthosis should also be self-adjustable or easily modified to account for the variable lower extremity mechanical factors. The orthosis should treat the leg, ankle and foot as a system complex functioning through the total gait cycle. The foot orthosis should not be limited to the treatment of positional static biomechanical microcosms of the lower extremities. For example, static orthotic inserts, having a depression or a support, are commonly used to accommodate a callus. A callus however, should usually be treated dynamically because a callus is predominantly a functional foot problem. Unfortunately, the knowledge currently available does not include a direct treatment method to accomplish the results that the instant invention provides.
Sophisticated clinical examination techniques and, in some cases, computer monitored "pressure data" studies are used to establish a biomechanical basis and to confirm the effectiveness of the prescribed treatment using shoe inserts. Yet, in many instances, the supportive orthotic treatment prescribed does not correct the patient's foot disorder. It is not unusual for a foot specialist to make an illogical, if not questionable adjustment to an insert, based upon current treatment options and knowledge, and find that the adjustment corrected the symptomatic condition. This is because treatment knowledge has overlooked direct functional application of the orthosis, which is sometimes serendipitously achieved.
Because most patients can actually feel the normal neurological responses of the foot and lower extremities, they can often know when their body is more or less working properly as a result of their symptomatic conditions. Moreover, even when there is initial discomfort caused by an orthosis, the patient can often correctly predict future tolerance of the orthosis and improvement of the symptomatic condition. Although the foot specialist uses objective factors to correct foot disorders, he or she also uses subjective factors in evaluating the patients comfort with the prescribed orthosis. Therefore, the patient's subjective perspective can often be as important to correct treatment as the foot specialist's objective perspective.
Ideally, the objective of orthopedic foot treatment is to improve functional alignment and symptomology of the foot and lower extremities through as much of the gait cycle as possible. Generally speaking, even regarding mild foot pathology, an appropriate surgery is more likely to achieve the long-term goal of treatment in comparison with the use of a contemporary foot orthosis. The reason for the higher success rate of surgery is at least in part, because surgery can provide a more permanent functional alignment and symptomatic improvement. In addition, the combination of wear changing characteristics of a shoe and a conventional supportive orthotic insert which flattens with use, can be unpredictable. Another reason is because there is no conveniently effective positive adjustment mechanism for the inevitable deteriorating change of the shoe or insert.
Because of the expense, discomfort and potential risks associated with surgery, orthotic treatment devices are widely used to improve symptomatic conditions of the foot and lower extremities. Even with our most advanced analytical techniques however, we have only a basic idea of how each individual biomechanical system works as an efficient unit. This is especially true with respect to the foot and lower extremities. We know that we can alter the walking surface by using a shoe insert. The change in a walking surface creates a biomechanical system reaction extending from the foot proximally to the axial skeleton. In time, changing the position of the foot's anatomical alignment by supporting it with an insert can modify system function with the possibility of influencing the biomechanical activity through the total gait cycle. Nevertheless, current insert adjustments, even when effective, almost universally are considered by patients and doctors to be inconvenient, time consuming and costly. The result can be that the patient who needs to be treated will avoid seeing a foot specialist for as long as possible. This delay can cause the condition of the patient to deteriorate further.
What is needed is a shoe insert design and method of treatment that will allow the wearer to experience direct and immediate functional benefit and to make simple adjustments for improved function. Improved function should result in improved anatomical alignment. The patient should be able to take an active responsibility in the empirical treatment of themselves, with respect to varying circumstances. The device should allow a dynamic interaction between the wearer, the shoe and the insert to place the patient in more effective control of his or her treatment plan. Further, the orthosis should be adaptable to many types of conventional foot orthoses to enhance their capability to improve function and comfort to the wearer.